The production licenses for nearly 170,000 medicines will be reviewed under strict quality examination procedures before they expire at the end of the year, according to the State Food and Drug Administration (SFDA). The campaign will begin in the second half of the year to re-examine drug companies who acquired a ...

2007-01-29

The production licenses for nearly 170,000 medicines will be reviewed under strict quality examination procedures before they expire at the end of the year, according to the State Food and Drug Administration (SFDA).

The campaign will begin in the second half of the year to re-examine drug companies who acquired a Good Manufacturing Practice (GMP) certificate for registering new medicines in 2004 and 2005. Drugs that fail the tests will be removed from the market.

The GMP certificate's credibility has been repeatedly called into question by a number of health scares caused by poor-quality pharmaceuticals. The most notorious case came to light last July when "Xinfu" antibiotic injections, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Company, caused the deaths of at least six patients and severe reactions in more than 80 others.

The SFDA carried out 35 unannounced inspections of drug manufacturers last companies last September and stripped 15 companies of their GMP certificates.

Due to the lax registration system, many Chinese pharmaceutical companies have copied existing products, registered them as new ones and sold them at much higher prices.

By last August, the SFDA had issued licenses for 168,740 new drugs and established a special data base for the license numbers and the ingredients of all new drugs.

"Whether or not the pharmaceutical enterprises can have their licenses renewed will mainly depend on the track records shown in the database," said a SFDA statement.

China is home to nearly 5,000 pharmaceutical manufacturers but only a few famous brands. "Redundant production has led to oversupply and reduced competitiveness," said Liu Yanming, an analyst with the China Galaxy Securities Co., Ltd.

Analysts say a stricter re-registration system for existing drugs is expected to help eliminate shabby products from the market, improve the research and development capabilities of pharmaceutical companies and fuel mergers and acquisitions.